CPIVISION DIGITAL IMAGING SYSTEM

K061173 · Communications & Power Industries Canada, Inc. · OWB · Jun 9, 2006 · Radiology

Device Facts

• Record ID: K061173
• Device Name: CPIVISION DIGITAL IMAGING SYSTEM
• Applicant: Communications & Power Industries Canada, Inc.
• Product Code: OWB · Radiology
• Decision Date: Jun 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The CPIVision Digital Imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The CPIVision Digital Imaging allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic difficult or impossible to see using conventional imaging techniques. The CPIVision Digital Imaging enables the operator to hardcopy image with a laser printer or send images over a network. The major system components are: a fluoroscopic CCD camera/lens, monitors, and an image processor.

Device Story

System captures analog video output from image intensifier via CCD camera/lens; digitizes signal for processing and display. Components include CCD camera, monitors, and image processor. Used in clinical settings (general/interventional fluoroscopy, angiography, cardiac imaging) by medical professionals. Operator performs image enhancement (brightness, contrast, edge enhancement, zoom, subtraction) to improve diagnostic visibility. System supports single or rapid acquisition of high-resolution digital spot images. Output displayed on monitors, stored on hard drive, printed via laser printer, or transmitted via network. Enhances clinical decision-making by providing superior visualization compared to conventional film techniques.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System utilizes a CCD camera/lens mounted to an image intensifier output port. Features digital image processor for signal digitization and enhancement. Connectivity includes network transmission and laser printer output. Operates as an add-on to conventional X-ray systems.

Indications for Use

Indicated for patients undergoing general fluoroscopy, interventional fluoroscopy, angiography, or cardiac imaging procedures where digital imaging is used to replace conventional film techniques.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• ORION FLUOROSCOPIC IMAGING SYSTEM (K012490)

Submission Summary (Full Text)

{0}------------------------------------------------

K061173

ર-।

Section S

# 510 (k) Summary of Safety and Effectiveness

| Date Prepared: | April 16, 2006 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Contact Person: | Norm Morikawa |
| Address: | Communications & Power Industries Canada Inc.<br>Communications & Medical Products Division<br>45 River Drive, Georgetown, Ontario, L7G 2J4, Canada |
| Telephone: | 905-877-0161 |
| Fax: | 905-877-5327 |
| Device Trade Name: | CPIVISION DIGITAL IMAGING SYSTEM |
| Common Name: | Digital Radiography |
| Classification Name: | Image Intensified Fluoroscopic X-ray System |

### Device Description:

The CPIVision Digital Imaging system allows the use of digital imaging to be applicd to conventional X-ray system used in general fluoroscopy, interventional fluoroscopy, angiography and cardiac imaging areas. The system works by installing a CCD camerallens on the output port of the image intensifier and digitizing the video output on the image intensifier. The digital image can be displayed on the monitor: it can be stored to the hard drive, or sent to an external device such as a laser imager or Network Storage Provider. The image can also be computer processed, including brightness and contrast, edge enhancement, zoom, and subtraction.

### Intended Use:

The CPIVision Digital Imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.

The CPIVision Digital Imaging allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic difficult or impossible to see using conventional imaging techniques.

{1}------------------------------------------------

The CPIVision Digital Imaging enables the operator to hardcopy image with a laser printer or send images over a network. The major system components are: a fluoroscopic CCD camera/lens, monitors, and an image processor.

### Conclusion drawn from comparison:

The CPIVision Digital Imaging can be considered to be substantially equivalent to:

#### INFIMED INC.

ORION FLUOROSCOPIC IMAGING SYSTEM 510 (k) – K012490

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. Norm Marikawa QA Manager/Regulatory Affairs CPI (Communications & Power Industries) Canada, Inc. Communications & Medical Products 45 River Drive, Georgetown, Ontario, L7G 2J4 CANADA

Re: K061173

Trade/Device Name: CPIVision Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: April 17, 2006 Received: April 27, 2006

Dear Mr. Morikawa:

This letter corrects our substantially equivalent letter of June 9, 2006.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of

MAY - 7 20-2

{3}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Section 4

## Indications for Use

Not to will at this time KO6 1 73 510(k) Number:

Device Name: CPIVision Digital Imaging System

Indications for Use: The CPIVision Digital Imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.

> The CPIVision Digital Imaging system allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques.

> The CPIVision Digital Imaging system enables the operator to hardcopy image with a laser printer or send images over a network. The major system includes: a fluoroscopic CCD camera/lens, monitors, and an image processor.

Prescription Device √

Concurrence of CDRH, Office of Device Evaluation (ODE.

Daniel R. Tyson
Division Sign Off